The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension

The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345124

Enrollment

Registered

2006-06-27

Start date

2006-05-31

Completion date

2009-08-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension and Healthy Controls

Keywords

urinary aquaporin-2, ENaC, fractional sodium excretion, High/low sodium diet

Brief summary

The aim of the study is to test the following hypotheses: * that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension. * if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.

Interventions

BEHAVIORALhigh sodium diet

250-350 mmol

BEHAVIORALLow Sodium Diet

25-35 mmol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Caucasian men and women * Age 18-65 years * Arterial hypertension * Body mass index between 18.5 and 30 kg/m2

Exclusion criteria

* Secondary hypertension * Isolated systolic hypertension * History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure. * Malignant disease * Prior apoplexy * alcohol or drug abuse * Drug use except antihypertensives and oral contraceptives * Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (\> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose. * Abnormal screening of the urine regarding: Blood, albumine and glucose. * abnormal electrocardiogram * Blood donation within one month of the first examination day * Unwillingness to participate

Design outcomes

Primary

Measure	Time frame
u-AQP-2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
fractional sodium excretion	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-vasopressin	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-aldosterone	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary

Measure	Time frame
uPGE2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
u-p-AQP-2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
GFR	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
u-ENaC(alfa,beta,gamma)	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
CH2O	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
u-cAMP	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026